Preterm Premature Rupture of MembranesPEACENCT01431248
PPROM Erythromycin Versus Azithromycin
An observational study of Preterm Premature Rupture of Membranes, run by University of Oklahoma.
Trial summary
Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in stomach upset in some patients, causing them to stop taking the medication. Therefore, azithromycin is often prescribed instead. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Premature Rupture of Membranes
- Type of treatment
- Injection or infusion
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women with the diagnosis of PPROM will be enrolled in this protocol.
Who may be able to join
- Pregnant women at least 18 years old
- Gestational age of 24 0/7 to 32 0/7 weeks
- Singleton gestation
- Randomization within 36 hours of rupture of membranes.
- Cervical dilation less than or equal to 4 cm.
Who cannot join
- Known lethal fetal anomaly
- Vaginal bleeding
- Maternal or fetal indication for delivery
- Diagnosis of chorioamnionitis on admission
- Cervical cerclage in place
- Placenta previa or other known placental anomalies
- Use of antibiotic therapy within 5 days.
- Allergy or other contraindications to erythromycin/azithromycin or steroid use.
About this study
Official title: Preterm Premature Rupture of Membranes: Erythromycin Versus Azithromycin. A Randomized Trial Comparing Their Efficacy to Prolong Latency
Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in stomach upset in some patients, causing them to stop taking the medication. Therefore, azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The working hypothesis is that there is no difference in the clinical effectiveness between antibiotic regimens containing te macrolides azithromycin and erythromycin for prolonging latency in PPROM.
Read the detailed description
The current standard regimen for PPROM patients between the gestational age of 24 0/7 and 32 0/7 weeks, is to administer ampicillin 2gm IV every 6hours for 48hrs followed by amoxicillin 250mg orally every 8 hours for 5 days, with erythromycin 250mg IV for 48hours followed by 500mg orally every 8hours for 5 days. Our study design would be a prospective randomized trial. Consented, eligible women will be randomized to receive ampicillin as above plus either azithromycin 1 gm orally at enrollment or erythromycin 250mg IV every 6 hours for 48hours followed by 500mg orally every 8hours for 5 days. Those who are unable to tolerate the 1gm of azithromycin within the first 30 minutes of administration, a 1000mg powder suspension will be given. In conjunction with standard protocol, a course of steroids for fetal lung maturity will be administered upon the treating staff's discretion, and all Group B Beta Streptococcus positive patients will be treated.
- Conditions
- Preterm Premature Rupture of Membranes
- Keywords
- Preterm Premature Rupture of Membranes, Erythromycin, Azithromycin
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Azithromycin 1gm PO once | |
| Erythromycin 250mg | Erythromycin 250mg IV Q 6hrs x 48 hours followed by 500 mg PO Q 8 hours x 5 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to delivery
To compare the mean time to delivery, using azithromycin versus erythromycin to prolong latency in PPROM patients. The working hypothesis for this aim is that there is no difference in the clinical effectiveness between antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging latency in PPROM.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Premature Rupture of MembranesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Eric Knudtson, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431248
- Sponsor's protocol ID
- PEACE
- Acronym
- PEACE
- Status last verified
- Jan 2013
- First submitted
- 7 Sep 2011
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Premature Rupture of Membranes: Erythromycin Versus Azithromycin. A Randomized Trial Comparing Their Efficacy to Prolong Latency
- ClinicalTrials.gov ID
- NCT01431248
- Acronym / sponsor ID
- PEACE / PEACE
- Conditions
- Preterm Premature Rupture of Membranes
- Keywords
- Preterm Premature Rupture of Membranes, Erythromycin, Azithromycin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Indiana University
- Study start
- Sep 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm Premature Rupture of Membranes (PPROM) is treated with an antibiotic, erythromycin or azithromycin, to prolong pregnancy. Erythromycin is taken for several days and can result in stomach upset in some patients, causing them to stop taking the medication. Therefore, azithromycin is often prescribed instead. Azithromycin is usually taken only once and stomach upset is not seen or greatly reduced. The goal of this study is to see if there is a difference between the antibiotic (azithromycin) compared to the antibiotic (erythromycin) in prolonging pregnancy in patients with Preterm Premature Rupture of Membranes (PPROM). The working hypothesis is that there is no difference in the clinical effectiveness between antibiotic regimens containing te macrolides azithromycin and erythromycin for prolonging latency in PPROM.
Detailed description
The current standard regimen for PPROM patients between the gestational age of 24 0/7 and 32 0/7 weeks, is to administer ampicillin 2gm IV every 6hours for 48hrs followed by amoxicillin 250mg orally every 8 hours for 5 days, with erythromycin 250mg IV for 48hours followed by 500mg orally every 8hours for 5 days. Our study design would be a prospective randomized trial. Consented, eligible women will be randomized to receive ampicillin as above plus either azithromycin 1 gm orally at enrollment or erythromycin 250mg IV every 6 hours for 48hours followed by 500mg orally every 8hours for 5 days. Those who are unable to tolerate the 1gm of azithromycin within the first 30 minutes of administration, a 1000mg powder suspension will be given. In conjunction with standard protocol, a course of steroids for fetal lung maturity will be administered upon the treating staff's discretion, and all Group B Beta Streptococcus positive patients will be treated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | – | –Azithromycin 1gm PO once |
| Erythromycin 250mg | – | –Erythromycin 250mg IV Q 6hrs x 48 hours followed by 500 mg PO Q 8 hours x 5 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with the diagnosis of PPROM will be enrolled in this protocol.
Key inclusion criteria (5 listed)
- Pregnant women at least 18 years old
- Gestational age of 24 0/7 to 32 0/7 weeks
- Singleton gestation
- Randomization within 36 hours of rupture of membranes.
- Cervical dilation less than or equal to 4 cm.
Key exclusion criteria (8 listed)
- Known lethal fetal anomaly
- Vaginal bleeding
- Maternal or fetal indication for delivery
- Diagnosis of chorioamnionitis on admission
- Cervical cerclage in place
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to delivery
Time frame: 2 years
To compare the mean time to delivery, using azithromycin versus erythromycin to prolong latency in PPROM patients. The working hypothesis for this aim is that there is no difference in the clinical effectiveness between antibiotic regimens containing the macrolides azithromycin and erythromycin for prolonging latency in PPROM.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Knudtson, MD principal investigator
University of Oklahoma
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Premature Rupture of Membranes, run by University of Oklahoma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to delivery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.